Dynamic CT Imaging After Nellix Endoprosthesis Implantation

NCT ID: NCT02438605

Last Updated: 2016-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-02-29

Brief Summary

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The Nellix Endovascular Sealing Prosthesis (EVAS) endoprosthesis is a new device aimed at prophylactic treatment of abdominal aortic aneurysms. In regular follow up conventional CT-imaging is used for surveillance. In this study dynamic CT imaging in patients pre- and post-operative will be assessed for device changes and anatomical variances.

Detailed Description

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Conditions

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Aortic Aneurysm

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment group

Patients eligible for AAA repair using Nellix and willing to participate in this trial.

Nellix

Intervention Type DEVICE

Interventions

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Nellix

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Nellix implantation

Exclusion Criteria

* Use of chimneys or combined with other stent graft material
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rijnstate Hospital

OTHER

Sponsor Role lead

Responsible Party

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Michel Reijnen

M.D., PhD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rijnstate Hospital

Arnhem, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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StM 596

Identifier Type: -

Identifier Source: org_study_id

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